Quetiapine Compared With Placebo in the Management of Fibromyalgia
Is quetiapine more effective than other medications in the treatment of fibromyalgia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Quetiapine Compared With Placebo in the Management of Fibromyalgia|
- Fibromyalgia Impact Questionnaire [ Time Frame: At 25 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Quetiapine
Quetiapine will be administered orally, QHS at a dosage of 100 mg for 1 week increasing to a target dosage of 200 mg for 11 weeks.
100 mg (peach colored oblong tablet) and 200 mg (yellow colored oblong tablet)
Other Name: Seroquel
Placebo Comparator: Sugar pill
Sugar pill will be administered orally, QHS at a dosage of 100 mg for 1 week increasing to a target dosage of 200 mg for 11 weeks.
This study is a double blind, placebo controlled, 24-week crossover design. For 12 weeks subjects receive either study medication (200mg Quetiapine) or placebo, after which they will be switched to the other treatment for an additional 12 weeks. Between treatments, subjects are required to undergo a 1-week washout where no drug is given in order to clear the effects of the first treatment. At each visit subjects will complete the following assessment: Fibromyalgia Impact Questionnaire, Pittsburgh Sleep Quality Index, Beck Depression Inventory, State-Trait Anxiety Inventory, and Short Form Health Survey. Temperature, blood pressure, pulse rate, weight and waist circumference will also be recorded. Physical exams and blood tests will be performed at 1, 12, and 25 weeks
|United States, Tennessee|
|East Tennessee State University|
|Johnson City, Tennessee, United States, 37614|
|Principal Investigator:||Norman C Moore, M.D.||East Tennessee State University|